Occupational Exposures to Hepatitis B and C

Recommendation: When an occupational exposure occurs, the source patient should be evaluated for both hepatitis B and hepatitis C. (AII)

The risk of transmission of HBV and HCV from an occupational exposure is significantly greater than the risk of HIV transmission. The risk of HCV infection following a needlestick is 1.8%, whereas the risk of HBV infection ranges from 1% to 30% depending on the presence of hepatitis e antigen (see Table 8). The risk of transmission of HCV from a single mucous membrane exposure is negligible.

Table 8. Average Risk for Transmission of Hepatitis B and C Viruses After Needlestick Compared With HIV

Source

Risk

HBV
HBeAg+ HBeAg-

22.0% - 30.0%1.0% - 6.0%

HCV+

1.8%

HIV+

0.3%

Hepatitis B Virus Post-Exposure Management

Recommendations:

• The hepatitis B vaccine series should be initiated in non-HBV-immune exposed workers who sustain a blood or body fluid exposure. (AI)

• Determination of antibody response of previously vaccinated exposed workers should be based on information available at presentation. Decision-making should not be delayed while testing for anti-HBs (see Table 9).

• Administration of prophylactic hepatitis B immune globulin (HBIG) and the initiation of the hepatitis B vaccine series injected at different sites is recommended when the non-HBV-immune exposed worker sustains a blood or body fluid exposure to a source patient with known acute or active HBV (see Table 9). (AI) Both HBIG and the first dose of the hepatitis B vaccine series should be ideally administered within 24 hours of exposure (AII); HBIG should not be given later than 14 days post-exposure. The three-dose HBV vaccine series is given at 0, 1 to 2 months, and 6 months. Hepatitis B antibodies should be obtained 1 to 2 months after completion of the third dose of the vaccine.

• Needlestick injuries and wounds should be washed with soap and water and should not be squeezed. Mucous membranes should be flushed with water. (AIII)

Initiation of the HBV vaccine series within 12 to 24 hours of an exposure has been demonstrated to be 70% to 90% effective in preventing HBV infection. The combination of vaccine and HBIG achieves a similar level of efficacy. Among known non-responders to vaccination, one dose of HBIG is 70% to 90% effective in preventing HBV when administered within 7 days of percutaneous HBV exposure,[34] and multiple doses have been shown to be 75% to 95% effective.[35] Pregnant women can safely receive both the HBV vaccination and HBIG.

When considering PEP for HBV exposures, both the source patient’s HBsAg status and the exposed worker's vaccination status should be considered (see Table 9). Determination of antibody response of previously vaccinated exposed workers should be based on information available at presentation. It is not recommended that decision-making be delayed while testing for anti-HBs. If antibody response is unknown, follow recommendations for "antibody response unknown" in Table 9.

Both HBIG and the first dose of the hepatitis B vaccine should be ideally administered within 24 hours of exposure; HBIG should not be given later than 14 days post-exposure. The three-dose HBV vaccine series is given at 0, 1 to 2 months, and 6 months. Hepatitis B antibodies should be obtained 1 to 2 months after completion of the third dose of the vaccine.

Even if the risk of exposure to HBV is not deemed significant, HBV vaccination should still be advised for all non-HBV-immune exposed workers (see Hepatitis B Virus guidelines for more information). Household, sex, and needle-sharing contacts of HBsAg-positive individuals should be identified and vaccinated according to the guidelines for patients exposed to known HBsAg-positive individuals.

No treatment unless known high-risk source; if high-risk source,f then treat as if source were HBsAg positive

Previously vaccinated,c antibody response unknown

Single vaccine booster dose

No treatment

No treatment unless known high-risk source; if high-risk source,f then treat as if source were HBsAg positive

If still undergoing vaccination

HBIGb ×1; complete series

Complete series

Complete series

aPersons who have previously been infected with HBV are immune to re-infection and do not require PEP. bDose 0.06 mL/kg intramuscularly. cVaccinated with full three-dose series. dBased on information available at presentation. Responder is defined as person with previously documented adequate levels of serum antibody to HBsAg (serum anti-HBs ≥10 mIU/mL); non-responder is a person with previously documented inadequate response to vaccination (serum anti HBs < 10 mIU/mL). It is not recommended that decision-making be delayed while testing for anti-HBs at presentation. eThe option of giving one dose of HBIG and re-initiating the vaccine series is preferred for non-responders who have not completed a second three-dose vaccine series. For persons who previously completed a second vaccine series but failed to respond, two doses of HBIG are preferred. fHigh-risk is defined as sources who engage in needle-sharing or high-risk sexual behaviors, and those born in geographic areas with HBsAg prevalence of ≥ 2%.[36]

Hepatitis C Virus Post-Exposure Management

Recommendations:

Clinicians should consider concurrent exposure to HCV when exposed workers present with an HIV exposure. (AII)

When HCV infection is identified, the exposed worker should be referred for medical management to a clinician with experience in treating HCV. (AII)

Currently, no effective prophylaxis for HCV has been identified. Immunoglobulin and antiviral agents are not recommended for HCV post-exposure prophylaxis (PEP). However, if an individual becomes acutely infected with hepatitis C and is diagnosed at that time, immediate referral to a specialist experienced in the treatment of hepatitis C is strongly recommended. Recent data suggest that early treatment of acute hepatitis C with interferon is highly effective, perhaps as high as 98%.[37] The best regimen or duration of therapy is unknown. However, observation for a period of 8 to 12 weeks post-infection is reasonable to assess for possible spontaneous resolution of acute hepatitis C.[38] Whether standard interferon or pegylated-interferon with or without ribavirin is used will depend on the individual scenario, as there have been no randomized, controlled trials to guide this decision.

Baseline Management

Recommendations:

Following an exposure to blood or body fluid, the clinician should assess the risk for exposure to HCV. (AII) Wounds should be washed with soap and water, and should not be squeezed. (AII) Mucous membranes should be flushed with water.

Once the clinician has determined that exposure to blood or body fluid has occurred, the following baseline tests should be obtained (see Table 10 for follow-up according to baseline results):

Exposed worker: Follow up as outlined in Post-Exposure Follow-Up for HCV, below

Exposed worker tests positive for both HCV antibody and HCV RNA

Counsel and manage as chronic hepatitis C

aRefer to Appendix E for information about HCV tests and how to interpret results. bIf at any time the serum ALT level is elevated in the exposed worker, the clinician should test for HCV RNA to assess for acute HCV infection. cA single negative HCV RNA result does not exclude active infection.

Clinicians should educate exposed workers about the natural history of HCV infection and should counsel exposed workers about the following:

Avoidance of alcohol and, if possible, medications that may be toxic to the liver

Risk of transmission related to:

Blood-to-blood contact, including sharing personal care items that may have come in contact with another person's blood, such as razors or toothbrushes; occupational needlestick injuries; and sharing needles, syringes, or other equipment to inject drugs

Breastfeeding: HCV is not transmitted by breastfeeding; however, clinicians should advise women who may have been exposed to HIV to avoid breastfeeding for 3 months after the exposure

Factors that may increase the risk of sexual transmission include sex with multiple partners, history of STIs, including HIV, or any other practice that might disrupt mucous membranes. The potential need for mental health counseling should be anticipated and offered as needed.

Post-Exposure Follow-Up for HCV

Recommendations:

If the source patient is known to be positive for HCV antibody and/or HCV RNA, the follow-up schedule for the exposed worker should be as follows (AII):

Week 4: HCV RNA and liver panel

Week 12: HCV RNA and liver panel

Week 24: Liver panel and HCV antibody

If at any time the serum ALT level is elevated, the clinician should repeat HCV RNA testing to confirm acute HCV infection. (AIII)

At any time that exposed workers test positive for HCV RNA, the clinician should refer for medical management and possible treatment by a clinician with experience in treating HCV. (AIII)

For individuals exposed to hepatitis C-infected source patients, regular follow-up with HCV RNA testing is recommended in addition to HCV antibody testing, because HCV RNA testing can identify acute infection within 2 weeks of exposure, whereas accuracy of the antibody test can be delayed up to several months after acute infection (ie, "window period").

Seroconversion with the ELISA antibody test occurs in 50% of patients within 9 weeks of exposure, in 80% of patients within 15 weeks of exposure, and in at least 97% of patients within 6 months of exposure.[39] The ELISA test is highly sensitive but relatively nonspecific, resulting in a low positive predictive value in low-prevalence populations. Positive HCV ELISA antibody test results require confirmation by a quantitative viral load assay, such as HCV PCR.

Sidebar

Appendix A. Antiretroviral Drugs

The tables that follow include antiretroviral agents recommended for PEP (tenofovir, emtricitabine, raltegravir) as well as alternative antiretroviral drugs that may be used in the setting of potential HIV resistance, toxicity risks, or constraints on the availability of particular agents. For information on all antiretroviral medications, see Antiretroviral Therapy.

The following tables indicate dosage and dose adjustment, potential adverse events and drug interactions, and FDA pregnancy categories as described below. Before using these drugs, package inserts should also be consulted.

A Adequate and well-controlled studies of pregnant women fail to demonstrate a risk to the fetus during the first trimester of pregnancy (and there is no evidence of risk during later trimesters).

B Animal reproduction studies fail to demonstrate a risk to the fetus and adequate and well-controlled studies of pregnant women have not been conducted.

C Safety in human pregnancy has not been determined, animal studies are either positive for fetal risk or have not been conducted, and the drug should not be used unless the potential benefit outweighs the potential risk to the fetus.

D Positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experiences, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks.

X Studies in animals or reports of adverse reactions have indicated that the risk associated with the use of the drug for pregnant women clearly outweighs any possible benefit.

Sidebar

Indication for PEP
Percutaneous or mucocutaneous exposure with blood or visibly bloody fluid or other potentially infectious material.

Indication for PEP
Percutaneous or mucocutaneous exposure with blood or visibly bloody fluid and the source patient is HIV-infected or likely to have HIV infection

HIV Testing of the Source Patient
If HIV serostatus of the source is unknown, voluntary HIV testing of the source should be sought. Rapid testing is strongly recommended for the source patient, and for those organizations subject to OSHA regulations, rapid testing of the source patient is mandated for occupational exposures. When the source patient's rapid test result is negative, and the clinician has ascertained that the source patient could have possibly been exposed to HIV in the previous 6 weeks, a plasma HIV RNA assay should be used in conjunction with the rapid HIV antibody test. In these situations, PEP should be initiated and continued until results of the plasma HIV RNA assay are available. In New York State, when the source patient has the capacity to consent to HIV testing, specific informed consent is required (see Appendix C).

HIV Testing of the Source Patient
Although concerns have been expressed regarding HIV-negative sources being in the window period for seroconversion, no case of transmission involving an exposure source during the window period has been reported in the United States. Rapid HIV testing of source patients can facilitate making timely decisions regarding use of HIV PEP after occupational exposures to sources of unknown HIV status

Recommendations for Number of Drugs in PEP Regimen
A three-drug PEP regimen is the preferred option for all significant-risk occupational exposures.

Recommendations for Number of Drugs in PEP Regimen
The decision to initiate 2- or 3-drug PEP regimens is based on the severity of the exposure and the level of risk for HIV transmission represented by the exposure (see CDC Tables 1 and 2).

HIV Antibody Testing of Healthcare Worker
After baseline testing, follow-up testing could be performed at 6 weeks, 12 weeks, and 6 months after exposure.

Timing of Initiation of PEP
When a potential occupational exposure to HIV occurs, every effort should be made to initiate PEP as soon as possible, ideally within 2 hours. A first dose of PEP should be offered to the exposed worker while the evaluation is underway. In addition, PEP should not be delayed while awaiting information about the source or results of the exposed individual's baseline HIV test.
Decisions regarding initiation of PEP beyond 36 hours post exposure should be made on a case-by-case basis with the realization of diminished efficacy when timing of initiation is prolonged.

Timing of Initiation of PEP
PEP should be initiated as soon as possible, preferably within hours rather than days of exposure. If a question exists concerning which antiretroviral drugs to use, or whether to use a basic or expanded regimen, the basic regimen should be started immediately rather than delay PEP administration.

Centers for Disease Control and Prevention. Updated U.S. Public Health Service guidelines for the management of occupational exposures to HIV and recommendations for postexposure prophylaxis. MMWR Morb Mortal Wkly Rep. 2005;54(RR-09):1-17. Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5409a1.htm

Sidebar

Organizations that employ health professionals or other persons who are at risk for occupational exposure to blood, body fluids, or other potentially infectious materials are generally required to establish policies and procedures that guide the management of such exposures. Employers must conform to the OSHA Bloodborne Pathogen Standard (OSHA Bloodborne Pathogen Standard 29 CFR § 1910.1030, and Compliance Directive CPL 02-02-069, 11/27/01, Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens), which are applicable to New York public employers under the New York Public Employee Safety and Health (PESH) Act (Labor Law § 27-a) and regulations (12 NYCRR Part 800). OSHA and PESH standards with regard to occupational exposure to bloodborne pathogens are identical. These regulations require that a management plan be in place.

The employer should ensure that any employee who sustains an occupational exposure has access to post-exposure services within 1 to 2 hours of a reported event. Services must be available 24 hours per day, 7 days per week. Organizations that do not have on-site occupational health services are encouraged to form agreements or contracts with another facility, Emergency Department, or private practitioner for such services.

Definition of Persons Covered

New York State regulations apply to staff, employees, or volunteers in the performance of employment or professional duties in:

A medical or dental office.

A facility regulated, authorized, or supervised by the Department of Health, Office of Mental Health, Office of Mental Retardation and Developmental Disabilities, Office of Children and Family Services, Office of Alcoholism and Substance Abuse Services, or the Department of Correctional Services.

Emergency response employee (paid or volunteer, including an emergency medical technician, a firefighter, a law enforcement officer or local correctional officer, or medical staff).

Post-exposure policies should define who is included as an "employee" for purposes of providing care. In addition to staff who are clearly employed by an organization (eg, nurses, laboratory personnel, housekeepers), consideration must be given to whether other individuals (eg, medical/nursing students, house staff, attending physicians, volunteers, and pre-hospital care personnel) will be covered by the institution’s policy. In addition, the scope of services that will be provided must be delineated (eg, laboratory testing, occupational health services, prophylactic drugs or vaccines), including whether there are limitations within the categories of individuals covered particularly with regard to Workers' Compensation benefits.

Access to Occupational Health Services

Exposed workers who sustain an occupational exposure should be ensured access to post-exposure services within 1 to 2 hours of a reported event. This may require 24-hour and weekend coverage. Procedures should identify how workers access services during regular work hours and, if different, how they access services during evening, night, or weekend shifts. Organizations that do not have on-site occupational health services should consider forming agreements or contracts with another facility or private practitioner for such services.

Post-exposure services for exposures to all bloodborne pathogens include but are not limited to:

Post-exposure evaluation and follow-up post-exposure vaccinations

Arrangements for a full course of post-exposure prophylaxis medications, at no cost to the employee

Care provided under the supervision of a licensed physician or other licensed healthcare professional

Availability of a rapid HIV test for source patient testing

Supportive counseling

Federal law requires covered employers to ensure that all medical evaluations and procedures, vaccines, and post-exposure prophylaxis are made available to the employee within a reasonable time and at a reasonable location and are made available at no cost to the employee (OSHA, 29 CFR, Part 1910.2030, CPL 2-02.069, 11/27/01, Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens).

PESH and OSHA's Bloodborne Pathogen Standards indicate that the covered employer is responsible for all costs associated with an exposure incident. An employer may not require any out-of-pocket expenditures on behalf of the employee, such as requiring the employee to utilize workers' compensation if prepayment is required or compelling an employee to use health insurance to cover these expenses unless the employer pays all premiums and deductible costs associated with the employees' health insurance. In addition to services listed above, NYS Guidelines state that the following should be considered by the employer when establishing plans for providing PEP for exposures to HIV:

who will perform the post-exposure evaluation

who will provide counseling to the exposed worker regarding the exposure and indications for PEP (for off-hour exposures as well)

how PEP will be made available within 2 hours of an exposure

how a 3- to 5-day supply of PEP will be made available for urgent use

who will be given authority for releasing drugs for this purpose

how the exposed worker will obtain PEP drugs to complete the 28-day regimen

Determining HIV Status of Source Patient

Procedures to facilitate rapid evaluation and voluntary testing for HIV, HBV, HCV and other bloodborne pathogens and/or disclosure of related information of the source individual should be in place.

The employer is responsible for establishing and implementing policies to protect the confidentiality of both the exposed employee and the exposure source (New York Public Health Law §§ 2135, 2782; 10 NYCRR § 63.6).

Access to Source Patient HIV-Related Information

New York law and regulations (Public Health Law § 2781(6)(e); 10 NYCRR § 63.8(m)) authorize disclosure of existing HIV-related information to providers of persons who have been exposed in the workplace when significant risk exposure has occurred.

When the source patient is already known to be infected with HBV, HCV, or HIV, testing for the source individual's known HBV, HCV, or HIV status does not need to be repeated. Testing for other bloodborne pathogens should still occur.

If the exposed worker is part of the healthcare team, he/she may have access to the medical record and know the HIV status of the source patient, as well as information about drug resistance. Information related to drug regimens, and, if available, resistance information, should be made available to the exposed employee's provider to determine the best regimen for the employee. However, initiation of PEP should not be delayed while awaiting this information.

HIV Testing of the Source Patient

Consistent with recommendations by the Centers for Disease Control and Prevention (CDC), the US Department of Labor, Occupational Safety and Health Administration (OSHA) mandates that medical facilities subject to OSHA authority use rapid HIV antibody tests when testing the source patient after potential exposure to a bloodborne pathogen.

The source patient should be tested as soon as possible to determine HIV infectivity.

Results of the source individual's HIV testing should be made available to the exposed worker's provider. Patient authorization for release of this information is not required for necessary communication of information from provider to provider for timely treatment of the exposed worker.

Source Patient Has Capacity to Consent for HIV Testing:

Informed consent from the source patient should be obtained.

If consent is not obtained for HIV testing, the employer should document that consent cannot be obtained and testing cannot be performed.

Source Patient Does Not Have Capacity to Consent for HIV Testing:

If the source is comatose or is determined by his or her attending professional to lack mental capacity to consent, and the source person is not expected to recover in time for the exposed person to receive appropriate medical treatment, the Health Care Proxy Law and Family Health Care Decisions Act (FHCDA) give providers the ability to locate someone who has the legal authority to consent to HIV testing (the healthcare agent or FHCDA Surrogate).

New York regulations (§§ 63.3(d)(7), 63.8(n)) also authorize anonymous testing when no person authorized to consent on behalf of the source patient is immediately available.

An anonymous test may be performed if:

the healthcare agent or FHCDA Surrogate, who has legal authority to consent, is not available or reasonably likely to become available in time for the exposed person to receive appropriate medical treatment,and

The law requires that results of anonymous source patient testing are given only to the provider of the exposed person solely for assisting the exposed person in making appropriate decisions regarding post-exposure medical treatment. The results of the test cannot be disclosed to the source patient or placed in the source patient’s medical record. The source patient may be told that the exposure occurred and an HIV test was performed. The source patient should be offered confidential testing so that they may have access to information about his/her own HIV status.

Workers' Compensation Program

The Workers' Compensation Law (WCL) has specific implications for employees exposed to HIV, as well as those rare cases that result in seroconversion. Individuals who manage such exposures should be familiar with these implications, as they should be able to counsel employees and refer them for legal and medical assistance accordingly. The organization's Workers' Compensation provider should be contacted as situations arise.

Reprinted from Cardo DM, Culver DH, Ciesielski CA, et al. A case-control study of HIV seroconversion in health care workers after percutaneous exposure: Centers for Disease Control and Prevention Needlestick Surveillance Group. N Engl J Med 1997;337:1485-1490.
aAll risk factors were significant (P < 0.02).
bAll risk factors were significant (P < 0.01).
cOdds ratios are for the odds of seroconversion after exposure in workers with the risk factor as compared with those without it.
dTerminal illness was defined as disease leading to the death of the source patient from AIDS within two months after the health care worker's exposure.

Sidebar

Table. Recommendations for Interpreting Results of Testing for Antibody to Hepatitis C Virus (Anti-HCV) by Type of Reflex Supplemental Testing Performed

Anti-HCV screening test results

Supplemental test results

Interpretation

Comments

Screening-test-negative*

Not applicable

Anti-HCV-negative

Not infected with HCV, unless recent infection is suspected or other evidence exists to indicate HCV infection

Screening-test-positive* with high signal-to-cut-off (s/co) ratio

Not done

Anti-HCV-positive

Probably indicates past or present HCV infection; supplemental serologic testing not performed. Samples with high s/co ratios usually (≥ 95%) confirm positive, but < 5 of every 100 might represent false-positives; more specific testing can be requested, if indicated

Screening-test-positive

RIBA-positive

Anti-HCV-positive

Indicates past or present HCV infection

Screening-test-positive

RIBA-negative

Anti-HCV-negative

Not infected with HCV, unless recent infection is suspected or other evidence exists to indicate HCV infection

Screening-test-positive

RIBA-negative

Anti-HCV-negative

Not infected with HCV, unless recent infection is suspected or other evidence exists to indicate HCV infection

Screening-test-positive

RIBA-indeterminate

Anti-HCV-indeterminate

HCV antibody and infection status cannot be determined; another sample should be collected for repeat anti-HCV testing (> 1 month) or for HCV RNA testing

Screening-test-positive

Nucleic acid test (NAT)-positive

Anti-HCV-positive, HCV RNA-positive

Indicates active HCV infection

Screening-test-positive

NAT-negative, RIBA-positive

Anti-HCV-negative, HCV RNA-positive

The presence of anti-HCV indicates past or present HCV infection; a single negative HCV RNA result does not rule out active infection

Screening-test-positive

NAT-negative, RIBA-negative

Anti-HCV-negative, HCV RNA-negative

Not infected with HCV

Screening-test-positive

NAT-negative, RIBA-indeterminate

Anti-HCV-negative, HCV RNA-negative

Screening test anti-HCV result probably a false-positive, which indicates no HCV infection

From Centers for Disease Control and Prevention. Guidelines for Laboratory Testing and Result Reporting of Antibody to Hepatitis C Virus. MMWR Recomm Rep. 2003;52(RR-03):1-16. Available at www.cdc.gov/mmwr/preview/mmwrhtml/rr5203a1.htm*Screening immunoassay test results interpreted as negative or positive on the basis of criteria provided by the manufacturer.